Lundbeck submits Selincro in EU; Novo Nordisk files Degludec in Japan

Danish CNS drug specialist Lundbeck (LUND: DC) revealed yesterday that it has submitted a marketing authorization application to the European Medicines Agency for Selincro (nalmefene), the company's novel opioid receptor ligand in development for alcohol dependence and the dossier has been accepted for review by EMA.

Lundbeck licensed the rights to Selincro from Finland’s Biotie Therapeutics, under the terms of which Biotie received an execution fee of 12 million euros ($15.6 million). In total, Biotie is eligible for up to 84 million euros in upfront and milestone payments plus royalty on sales. Lundbeck will be responsible for manufacturing and registration of the product.

"Alcohol dependence is a significant burden for both individuals and society with only limited medical treatment options. We are very pleased that we now are at a stage where we can start the regulatory review and approval process for Selincro in Europe," says Lundbeck executive vice president and head of R&D at Anders Gersel Pedersen, who noted: "Clinical studies have shown that Selincro is well-tolerated and with a demonstrated clinical benefit in reducing heavy drinking days and overall alcohol consumption".